Argentina – Regulation of Law N° 27.669 on the regulatory framework for the development of the medical cannabis and industrial hemp industry published

Decree N°405/2023 approved the regulation of Law N° 27.669, on the regulatory framework for the development of the medical cannabis and industrial hemp industry.

The regulation establishes the creation of the National Agency of Hemp and Industrial Cannabis (ARICCAME in Spanish), which will be the regulatory body that will operate within the Ministry of Economy.
The main novelty of the regulatory framework is that it considers “psychoactive cannabis” those plants with dried flowers that exceed 1% of tetrahydrocannabinol (THC) in their chemical composition, therefore, up to that percentage it is legal from now on to manufacture products based on the substance, without entering into conflict with criminal legislation or international regulations and without having to go through the approval of the National Agency of Medicines (ANMAT in Spanish) through a new category, the so-called “vegetable”, for products that are not of medical grade.

As enforcement authority of the law, ARICCAME will define the specifications and regulation of what is considered a “product derived” from cannabis: human medicinal, veterinary, nutritional, cosmetic, industrial, plant health and fertility, but the regulation itself leaves the door open for new functionalities, “arising from scientific research and technological and industrial development”. For example, the seed as food or the oil extracted from it is rich in Omega 3, 6 and 9. And the fiber, as a textile material, can replace others that are pollutants.

All licenses will be valid for a minimum of five years and will be renewable. There will be seven types of license: hatchery, multiplication and cultivation; logistic services (transport, distribution, storage, packaging, among others); production of derivatives; commercialization of seeds, seedlings, cuttings and flowers; for studies and analytical tests; and foreign trade.

Brazil – 3rd edition of nutrition labeling Q&A guide

The National Health Surveillance Agency (ANVISA in Portuguese) published the 3rd edition of the Q&A guide on nutrition labeling. This edition brings a revision of some guidelines on added sugars, after the evaluation of doubts and requests received by the General Directorate of Food (GGALI in Portuguese) on the subject and the discussions of the Virtual Sectorial Dialogue on Added Sugars, held last July 3.

Article/Mexico – Implementing front-of-pack nutrition warning labels in Mexico: important lessons for low and middle-income countries

OBJECTIVE: To analyze the implementation of front-of-pack nutrition labeling (FOPNL) in Mexico.
DESIGN: Review of publicly accessible documents, including legislative websites, news sources, and government, inter-governmental, and advocacy reports. Usage of the policy cycle model to analyze the implementation and evaluation stages of Mexico’s General Health Law, amended with FOPNL (2019-2022).
RESULTS: In October 2019, the government published a draft modification of the Norma Oficial Mexicana (Official Mexican Standard) to regulate and enforce a new FOPNL warning label system. A 60-day public consultation period followed (October-December 2019) and the regulation was published in March 2020 and implementation began in October 2020. An analysis of nine key provisions of the Standard revealed that the food and beverage industry and its allies weakened some original provisions including health claims, warnings for added sweeteners, and display areas. On the other hand, local and international public health groups maintained key regulations including the ban on cartoon character advertisements, standardized portions, and nutrient criteria following international best practices. Early implementation appears to have high compliance and helped contribute to reformulating unhealthy products. Continued barriers to implementation include industry efforts to create double fronts and market their cartoon characters on social media and through digitalized marketing.
CONCLUSION: Early success in implementing the new FOPNL system in Mexico was the result of an inclusive and participatory regulatory process dedicated to maintaining public health advances, local and international health advocacy support, and continued monitoring. Other countries proposing and enacting FOPNL should learn from the Mexican experience to maintain scientifically proven best practices, counter industry barriers and minimize delays in implementation.

Costa Rica – Ministry of Health issues statement ordering not to display nutrition warning labels on foods

The Directorate of Regulation of Products of Health Interest of the Ministry of Health ordered importers and distributors to hide the nutritional warning labels, usually contained in imported products, which warn about high contents of fats, saturated fats, sodium or sugars in the packaging of these products.

This is stated in the circular MS-DRPIS-UR-1588-2023 of June 22nd, of which Delfino.cr has a copy and whose authenticity was confirmed with the digital signatures of Priscilla Herrera García, director of the Registration Unit; and Andrea Morales Fiesler, head of the Registration Unit.

Brasil – ANVISA/Regulatory Agenda 2024-2025: preliminary list of topics is open for input

From July 31 to September 14, the society and the entities of the National Health Surveillance System (SNVS) will be able to give their opinion in the guided consultation on the preliminary list of topics proposed by Anvisa for prioritization in the RA 2024-2025. It is also possible to suggest the inclusion of other topics, in case any regulatory demand of interest is not present in the list.

Contributions can be sent through an electronic form, open to the participation of any interested party.

Food topics:

  • Review of legislation on the use of functional and/or health claims on foods.
  • General labeling of packaged foods.
  • Updated labeling requirements for major allergenic foods.
  • Labeling of foods intended for industrial purposes only.
  • Updated macroscopic and microscopic foreign matter requirements for cassava starch and flour and rice flour.
  • Sanitary requirements for silicone food contact materials.
  • Update of the regulatory framework for metallic food contact materials.
  • Update of sanitary requirements for dietary supplements (Revision of DRC No. 243/2018).
  • Edition of regulatory act on food for medical use.
  • Revision and consolidation of regulations on infant formula and enteral nutrition formulas
  • Revision of the regulation on food additives and food technology adjuvants.
  • Revision of the regulation of food additives and food technology adjuvants authorized for use in dairy products.
  • Re-evaluation of the authorization for the use of the food additive titanium dioxide in foods.
  • Nutrivigilance requirements applicable to the regulated sector, including those related to the establishment of a nutrivigilance system and the submission of mandatory periodic notifications and reports.
  • Revision of the standard for hygienic-sanitary requirements and good manufacturing practices for food producing or processing establishments.
  • Updating the regulatory framework for food irradiation.
  • Regulation of sanitary requirements for foods of plant origin.
  • Good practices for food services